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| ID | Type | Description | Link |
|---|---|---|---|
| MK0476-246 | |||
| 2009_659 |
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This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | montelukast |
|
| 2 | Active Comparator | cetirizine |
|
| 3 | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast sodium | Drug | montelukast 10 mg tablet orally once daily at bedtime for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Daytime Nasal Symptoms Score | Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score. | Baseline and first 4 weeks of a 6-week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Nighttime Symptoms Score | Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worst)], and the average score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. | Baseline and first 4 weeks in 6-week treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17619558 | Result | Philip G, Williams-Herman D, Patel P, Weinstein SF, Alon A, Gilles L, Tozzi CA, Dass SB, Reiss TF. Efficacy of montelukast for treating perennial allergic rhinitis. Allergy Asthma Proc. 2007 May-Jun;28(3):296-304. doi: 10.2500/aap.2007.28.3000. |
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Patients who required excluded medication and those who did not meet a minimum predefined level of combined daytime rhinitis symptoms score during the run-in period were excluded from randomization.
74 study sites in the United States
Primary Therapy: Nov-2001 to May-2002
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| ID | Title | Description |
|---|---|---|
| FG000 | Montelukast 10 mg | Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks. |
| FG001 | Cetirizine 10 mg | Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks. |
| FG002 | Placebo | Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Montelukast 10 mg | Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks. |
| BG001 | Cetirizine 10 mg | Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in Daytime Nasal Symptoms Score | Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score. | All patients who had a baseline and at least one posttreatment measurement were included. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and first 4 weeks of a 6-week treatment period |
|
During the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of patients listed in the Adverse Event tables (613 in the placebo group, 630 in the montelukast group, and 122 in the cetirizine group) is the number of patients who received study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Montelukast 10 mg | Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Laceration | Injury, poisoning and procedural complications | Merck CRISP Dict. | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Infection | Infections and infestations | Merck CRISP Dict. | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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| Comparator: cetirizine |
| Drug |
cetirizine 10 mg tablet orally once daily at bedtime for 6 weeks |
|
| Comparator: placebo | Drug | placebo tablet orally once daily at bedtime for 6 weeks |
|
| Mean Change From Baseline in Composite Symptoms Score | Composite Symptoms Scores were computed as the average of the Daytime Nasal Symptoms Scores [Score 0 (best) to 3 (worst)]. and Nighttime Symptoms Scores collected [Score 0 (best) to 3 (worst)]. | Baseline and first 4 weeks in 6-week treatment period |
| Patient's Global Evaluation of Allergic Rhinitis | An evaluation by the patient, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study. | End of the first 4 weeks in 6-week treatment period |
| Physician's Global Evaluation of Allergic Rhinitis | An evaluation by the physician, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study. | End of the first 4 weeks in 6-week treatment period |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Patient Moved |
|
| Other |
|
| BG002 | Placebo | Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Composite Symptoms score | Composite Symptoms Scores were computed as the average of the Daytime Nasal Symptoms Scores [Score 0 (best) to 3 (worst)] and Nighttime Symptoms Scores [Score 0 (best) to 3 (worst)]. | Mean | Standard Deviation | Scores on a scale |
|
| Daytime Nasal Symptoms score | Patients were asked to rate each of 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptom scores was reported as the Daytime Nasal Symptoms Score. | Mean | Standard Deviation | Scores on a scale |
|
| Nighttime Symptoms score | Patients were asked to rate each of 3 symptoms of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings daily on a 4-point scale [Score 0 (best) to 3 (worst)], and the average score of the 3 symptoms was reported as the Nighttime Symptoms Score. | Mean | Standard Deviation | Scores on a scale |
|
| Cetirizine 10 mg |
Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks. |
| OG002 | Placebo | Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks. |
|
|
| Secondary | Mean Change From Baseline in Nighttime Symptoms Score | Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worst)], and the average score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. | All patients who had a baseline and at least one posttreatment measurement were included. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Baseline and first 4 weeks in 6-week treatment period |
|
|
|
| Secondary | Mean Change From Baseline in Composite Symptoms Score | Composite Symptoms Scores were computed as the average of the Daytime Nasal Symptoms Scores [Score 0 (best) to 3 (worst)]. and Nighttime Symptoms Scores collected [Score 0 (best) to 3 (worst)]. | All patients who had a baseline and at least one posttreatment measurement were included. | Posted | Least Squares Mean | 95% Confidence Interval | Score 0 (best) to 3 (worst) | Baseline and first 4 weeks in 6-week treatment period |
|
|
|
| Secondary | Patient's Global Evaluation of Allergic Rhinitis | An evaluation by the patient, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study. | The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | End of the first 4 weeks in 6-week treatment period |
|
|
|
| Secondary | Physician's Global Evaluation of Allergic Rhinitis | An evaluation by the physician, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study. | The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | End of the first 4 weeks in 6-week treatment period |
|
|
|
| 2 |
| 630 |
| 85 |
| 630 |
| EG001 | Cetirizine 10 mg | Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks. | 0 | 122 | 16 | 122 |
| EG002 | Placebo | Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks. | 3 | 613 | 65 | 613 |
| Unstable Angina | Cardiac disorders | Merck CRISP Dict. | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Merck CRISP Dict. | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Merck CRISP Dict. | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |